Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- NeuraLight
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of saccadic latency between subgroups
研究概览
简要总结
This is an observational longitudinal study in 4 cohorts of patients with Parkinsonian syndromes, who are visiting the Movement Disorders outpatient clinics.
The aim of the study is to assess the difference of oculometric measures in different neurodegenerative brain conditions and their accuracy over time, and as compared to clinical diagnosis, in order to find a change over time, difference between subgroups and correlations with accepted clinical endpoints in subjects who meet the inclusion criteria and who provide a signed Informed Consent.
详细描述
As a part of the study, about 40 subjects will undergo a neurological evaluation including motor and cognitive assessments and a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye-tracking system (Tobii, CE-marked class B approved device). Test duration will be approx. 20 minutes. The oculometric evaluation will occur for at least 50% of the cohort 3 times (at baseline, at 6-months and at 12-month follow-up), and all subjects will be recruited over a period of 9 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, age between 40 and 80 years
- •<5 years since disease diagnosis
- •Normal or corrected vision
- •MOCA score ≥ 20
- •Ability to follow instructions
- •Willing and able to sign an informed consent form Specific
- •PD cohort: Ages 50-80, Hoehn & Yahr scale 1-3
- •PSP cohort: diagnosed according to actual diagnostic criteria from Höglinger GU et al,
- •MSA cohort: diagnosed according to actual diagnostic criteria from Wenning et al, 2022.
排除标准
- 未提供
研究组 & 干预措施
MSA patients
Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022.
干预措施: NeuraLight MSA (Other)
PSP patients
Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017.
干预措施: NeuraLight PSP (Other)
Parkinson patients
Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn & Yahr scale 1-3
干预措施: NeuraLight PD (Other)
Healthy
Healthy subjects with no neurological diseases or cognition deficits
干预措施: NeuraLight (Other)
结局指标
主要结局
Change of saccadic latency between subgroups
时间窗: 12 months
A difference between saccadic latency among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05)
Change of antisaccadic error rate between subgroups
时间窗: 12 months
A difference between antisaccadic error rate (%) among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05)
Change of saccadic latency over time as evaluated during visits
时间窗: 12 months
Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Change of antisaccadic error rate over time as evaluated during visits
时间窗: 12 months
Difference between antisaccadic error rate (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Correlation between MDS-UPDRS score and its parts with saccadic latency
时间窗: 12 months
The correlation between the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
Correlation between UMSARS score and its parts with saccadic latency
时间窗: 12 months
The correlation between the Unified Multiple System Atrophy Rating Scale (UMSARS) scored 0-to a maximum total of 48, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
Correlation between PSP-CDS and its parts with saccadic latency
时间窗: 12 months
The correlation between the Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS) scored 0-to a maximum total of 100, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
次要结局
- Correlation between MoCA score and its parts with anti-saccadic error rates(12 months)
- Correlation between MoCA score and its parts with smooth pursuit(12 months)